Clinical Trial Management Services in India
A thorough and customized solution that pays specific attention to the needs!
We are in a remarkable position to assist you in designing, developing, and implementing clinical trial solutions for your particular needs because Zenovel is a top-contract research organization with more than 19 years of clinical research experience.
Clinical trial services in India are research projects that examine how well brand-new medical techniques perform in actual patients. With the goal of collecting safety and efficacy data, data used to support regulatory submissions, and data used to support approvals across the globe, these biomedical and behavioral research studies are created to respond to specific inquiries concerning new therapeutic items or procedures.
They can seriously limit the accessibility of cutting-edge products that might make life better for patients and their families.
We can offer biotechnology and pharmaceutical firms the complete spectrum of CRO services. From research to delivery.
Medical and Scientific Writings:
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Protocol Writing
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Informed Consent
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Clinical Study Reports
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Clinical Evaluation Reports
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Investigator’s Brochure
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IMPD
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Patient Narratives
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Clinical and Nonclinical Summaries
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Pre-Submission Preparations
Regulatory Approval Support:
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Protocol Writing
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Informed Consent
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Clinical Study Reports
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Clinical Evaluation Reports
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Investigator’s Brochure
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IMPD
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Patient Narratives
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Clinical and Nonclinical Summaries
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Pre-Submission Preparations
Project Management:
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Project Planning
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Coordination and Oversight Management
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Investigator Meeting Management
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Training Management
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Primary liaison with sponsor, site, and team
Trial Monitoring and Management:
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Site Identification, Feasibility and Qualification
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Liaising and Contracting with sites
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Risk-Based Monitoring: Site Initiation, IMV and Closeout
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Central, Remote, and Virtual Trial Monitoring
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Site Audit
Data Management:
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Database Build, Validation, and Testing
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Data Cleaning
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Data Query Management
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Database Reconciliation
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System and User Management
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Database Lock
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CDISC Standardization
PK Statistics:
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Adaptive Trial Designs
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Power Analyses
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Statistical Programming and Analysis
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CSR, ISS/ISE, DSUR